East Carolina University - Greenville, SC

posted 5 months ago

Full-time - Entry Level
Greenville, SC
Educational Services

About the position

The Social Clinical Research Assistant position at East Carolina University (ECU) is designed to support the Office of Clinical Research (OCR) within the Brody School of Medicine (BSOM). This role is pivotal in ensuring that clinical research is conducted in compliance with federal regulations and institutional guidelines. The OCR aims to standardize clinical research practices across various research centers and departments, providing essential regulatory and operational assistance to investigative teams. The assistant will be involved in various aspects of research preparation, patient enrollment, data collection, and reporting, ensuring that all activities align with the study protocols and ethical standards. In this role, the assistant will coordinate with the research team to facilitate study requirements, assist in the development of study materials, and monitor research activities. They will also be responsible for preparing and maintaining regulatory documentation, including Institutional Review Board applications and consent forms. The assistant will play a crucial role in patient recruitment, screening for eligibility, and ensuring that informed consent is obtained. Data management is another key responsibility, where the assistant will collect and record study data, maintain patient logs, and assist with adverse event reporting. The position also involves clinical and patient care duties, ensuring that all procedures required by the study protocol are performed accurately. The assistant will aid in the collection and processing of biospecimens and assist with study-related procedures. Effective communication is essential, as the assistant will coordinate with various internal departments and maintain direct communication with principal investigators, clinical staff, and study participants. Additionally, the assistant will support financial documentation related to invoicing and budgeting for clinical trials. Overall, this position is integral to the successful execution of clinical research at ECU, contributing to the advancement of scientific knowledge and the provision of exemplary medical education and care.

Responsibilities

  • Assist the research team with study requirements to ensure compliance with protocols, federal regulations, and institutional guidelines.
  • Help develop study materials and monitor research activities in conjunction with the sponsor/research team.
  • Prepare and maintain regulatory and study documentation, including IRB applications and consent forms.
  • Screen patients for eligibility and assist in enrolling subjects into studies.
  • Collect data from patients and medical records, maintaining patient enrollment logs and files.
  • Support informed consent processes and educate patients about study participation.
  • Ensure procedures required by study protocol are performed and documented correctly.
  • Aid the lead coordinator with study-related procedures and track timelines outlined in the protocol.
  • Help with documentation of enrollments and produce related reports as requested.
  • Assist with financial documentation related to invoicing and budgeting for clinical trials.

Requirements

  • Bachelor's degree or equivalent combination of training and experience.
  • Experience with human subject research.
  • Familiarity with Electronic Medical Records (such as EPIC).
  • Experience working on clinical research projects.
  • Experience working in a research lab or clinical setting.
  • CITI ethics training.

Nice-to-haves

  • Experience in a clinical research environment.
  • Knowledge of regulatory compliance in clinical trials.

Benefits

  • Competitive hourly salary of $18.00 per hour.
  • Opportunity to gain experience in clinical research and patient care.
  • Access to professional development opportunities within the university.
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